Guide: What documentation to send to your PV consultants in 2025

As a marketing authorisation holder (MAH), you may delegate certain pharmacovigilance activities to a PV service provider such as PharmAdvice. However, as you retain full responsibility for these activities you must keep oversight of all PV activities and inform your PV service provider of all relevant PV matters.

In this article, you will find a list of the most common ongoing and annual pharmacovigilance activities and the documentation you are required to provide for each activity.

Your pharmacovigilance consultant will keep you informed of the due dates and any additional input needed.

Ongoing activities

If you have hired a PV service provider, you must keep them informed of your internal pharmacovigilance activities throughout the year. These activities include, but are not limited to:

• New or amended SmPCs or plans to amend them

• Recalls and considerations

• Product availability issues

• Adverse event reports received by you

• Any updates of your SOPs listed in the PSMF

• Any other changes requiring amendments to the PSMF

• Finalised PV training in your company.
  

Amendments to the summaries of product characteristics (SmPC)

Your PV service provider (with the qualified person responsible for pharmacovigilance (QPPV) as lead) must update the extended EudraVigilance Medicinal Product Dictionary (XEVMPD, also known as the Article 57 database) within 30 calendar days from the date of approval of product information changes and must have updated product knowledge at all times.

Therefore, it is crucial that you inform your QPPV of all amendments to or plans to amend the SmPC immediately – not least when amendments are made to sections 4.3-4.9.

Adverse event reports

In the event of you receiving an adverse event report or other safety-related information, you must inform your QPPV immediately. Check the inbox designated to adverse event reports and other safety information daily and document these checks.

Also make sure that you have standard operational procedures (SOP) and training in place for handling and reporting such information. Your PV service provider can advise you on this.

Pharmacovigilance System Master File (PSMF)

As the MAH, it is your responsibility to ensure that the pharmacovigilance system master file (PSMF) is updated, even when you delegate the task.

If the competent authorities request an updated pharmacovigilance system master file (PSMF), you have seven days to comply. This is why we strongly recommend that you send information about changes that may require PSMF updates to your QPPV continually rather than wait for the annual PSMF update.

This includes amendments to the following documents and annexes:

• Your organisation chart (Annex B)

• Agreements and contracts (Annex B)

• Safety data contacts (Annex C)

• Your PV SOPs and any general quality system SOPs in the MAH SOP list (Annex E)

• Planned and conducted PV audits conducted by you, the MAH (Annex G)

• Products and marketing authorisations covered by the PV system (Annex H).

Annual activities

Pharmacovigilance System Master File (PSMF)

The pharmacovigilance system master file (PSMF) must be updated at least once per year.

Typically, your PV service provider initiates the activity and sends you a draft for your review and inputs. To optimize the process and prepare for any ad-hoc updates, we recommend the draft to be continually updated, and it is important that you provide any amendments on your end on an ongoing basis. See above for a list of documentation requirements.

Documentation of the MAH’s pharmacovigilance activities

The QPPV is legally required to maintain oversight of PV activities at the MAH’s organisation.

For your QPPV to be able to do this, you must provide updated documentation of your internal PV activities on a regular basis:

PV-training at MAH

The person responsible for pharmacovigilance activities at your organization must document that:

• They have read and understood the Guideline on good pharmacovigilance practices (GVP) modules in force (modules I, II and III, at a minimum)

• They have completed training in your existing pharmacovigilance SOPs

• They have completed the annual training on adverse event management.

Employees covered by the scope of your SOP on handling adverse events or other safety information must document that:

• They have completed the annual training in adverse event management.

Training documentation should include SOP/document name and version number, employee name, date of training, and the employee’s signature.

Daily check of inbox for receipt of adverse events

You must document that you are checking the inbox dedicated to adverse event reports and other safety information daily. Your PV provider may provide you with a template for this.

Periodic safety reports

As a marketing authorisation holder (MAH) you are legally required to retain oversight of the safety profile of your medicinal products. Your external PV consultant performs various product safety surveillance activities and documents this in periodic safety reports (PSRs).

If your medicinal product requires periodic safety update reports (PSURs), your pharmacovigilance consultant prepares and submits these to the competent authorities in accordance with current standards and regulatory reporting timelines.

For the preparation of PSRs and PSURs, your QPPV will need the following information:

• Amendments to the SmPC

• Sales data for each product (countries, strengths, pack sizes).

Your PV consultant will keep you informed of the due dates and any additional input needed.